Phase III Study of Nuvastatic 300 mg Capsules to Reduce Chemotherapy-Related Fatigue in Women With Metastatic Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult women with metastatic triple-negative breast cancer undergoing first-line chemotherapy. This Phase III clinical trial compares Nuvastatic capsules to placebo to assess their effect on fatigue scores and safety in this patient population. Participants will take either Nuvastatic 300 mg capsules or placebo capsules three times a day for three cycles of 20 days each, totaling about 60 treatment days, while continuing their standard chemotherapy regimen. Blood samples will be collected at screening and at the end of treatment. Patients will also complete diaries and fatigue assessments according to the study protocol. During the trial, participants will be monitored through fatigue assessments and quality of life evaluations at baseline and study end, approximately six months later. The primary outcome is the reduction of cancer-related fatigue from screening to end of treatment. Safety and tolerability will be observed alongside quality of life and functional improvements. The total study duration includes screening, treatment, and follow-up assessments.

Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer